Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting), Stryker Triathlon Tritanium Knee System (Condylar Stabilizing).
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee, Knee Osteoarthritis, Osteoarthritis Knees Both, Osteoarthritis Knee Left. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
Overview
Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.
Detailed description
This is a single center, cohort study in 100 adult subjects undergoing primary total knee arthroplasty that will receive one of the two total knee device systems.
Primary total knee replacement is an effective treatment for relieving pain and improving function for patients with degenerative joint disease. Recently, design of knee implants in a total knee replacement have received increased interest, particularly the medial pivot designs. Single-radius implants are designed to minimize instability throughout the functional range of movement. Medial pivot total knee designs theoretically recreate more normal knee motion when compared to single radius designs. Both implant designs are commonly used for total knee replacements. Outcomes of TKA are evaluated by multiple methods including implant/device survivorship, radiographic assessments, clinical examinations, and patient reported outcome measures (PROMS). Laboratory based gait analysis performed at a specialized research facility is not commonly conducted in patients with positive outcomes post-surgery as this is associated with high cost. There is currently not enough research comparing these two designs directly. Research is required to determine which design may provide better clinical outcomes and satisfaction with the procedure.
In addition to your normal standard clinical care, there will be scheduled pre-operative, operative, 6-week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visits.
Interventions
- Device MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
Medial Pivot Knee System - Device Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Single Radius Design Total Knee System
Primary outcome measures
- Change in Knee Mechanics [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Anterior/Posterior Knee Translation [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Initial Peak Loading Force [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Active and Passive Range of Motion [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Quadriceps Lag [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Timed up and Go Test (TUG) [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Five Times Sit to Stand Test [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Single Limb Stance Test for Both Knees [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Timed Ascent and Descent of One Flight of Stairs Test [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
- Change in Quadriceps Muscle Strength [Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit]
Secondary outcome measures (7)
- Implant Survivorship [Time frame: Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit]
- Post-surgical Complications [Time frame: Operative visit; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit]
- Evidence of Osteolysis [Time frame: Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit]
- Change in Knee Society Score (KSS) Short Form [Time frame: Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit]
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit]
- Change in Patient Reported Outcomes Measurement Information System (PROMIS-10) [Time frame: Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit]
- Change in Forgotten Joint Score FJS [Time frame: Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit]
Eligibility criteria
Inclusion criteria
- Subject is male or non-pregnant female aged between 18 and 75 years of age.
- Subject is willing to provide informed consent to participate in the research study.
- Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS)
- Subject does not have a history of previous prosthetic replacement device on the operative knee.
- Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.
- Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.
Exclusion criteria
- Subject has a Body Mass Index (BMI) >40
- Subject has a diagnosis of avascular necrosis or inflammatory arthritis.
- Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- Subject is a prisoner
- Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Sinai Hospital of Baltimore — Baltimore
Identifiers
NCT: NCT04814082 · 1679091